PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun Medical	PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	piperacillin sodium; tazobactam sodium	POWDER;INTRAVENOUS	206056	NDA	B. Braun Medical Inc.	0264-3446-11	24 CONTAINER in 1 CASE (0264-3446-11) / 50 mL in 1 CONTAINER	2025-09-30
B Braun Medical	PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	piperacillin sodium; tazobactam sodium	POWDER;INTRAVENOUS	206056	NDA	B. Braun Medical Inc.	0264-3448-11	24 CONTAINER in 1 CASE (0264-3448-11) / 50 mL in 1 CONTAINER	2025-09-30
B Braun Medical	PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER	piperacillin sodium; tazobactam sodium	POWDER;INTRAVENOUS	206056	NDA	B. Braun Medical Inc.	0264-3450-22	24 CONTAINER in 1 CASE (0264-3450-22) / 100 mL in 1 CONTAINER	2025-09-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: October 5, 2025

Introduction

The global pharmaceutical market for antibiotics, particularly broad-spectrum agents like piperacillin and tazobactam combined with saline solutions such as sodium chloride in duplex containers, has experienced significant growth. These medications are crucial in managing severe bacterial infections, especially in hospital settings. Understanding the suppliers for such formulations—especially those packaged in duplex containers—can inform procurement strategies, ensure drug quality, and optimize supply chain resilience.

Overview of Piperacillin and Tazobactam with Sodium Chloride

Piperacillin is a broad-spectrum β-lactam antibiotic, effective against various Gram-positive and Gram-negative bacteria. It is frequently paired with tazobactam, a β-lactamase inhibitor, enhancing efficacy against resistant bacterial strains. When combined, these agents are commonly administered intravenously, often diluted with sodium chloride solutions for infusion.

Sodium chloride in duplex containers refers to packaged saline solutions, typically 0.9% NaCl, designed with dual compartments—one containing the drug powder and the other containing diluent—enabling reconstitution at the point of care.

Market Dynamics and Major Suppliers

The global supply chain for these pharmaceuticals encompasses multinational pharmaceutical corporations, generic drug manufacturers, and specialized infusion device providers. Their strategic manufacturing facilities span North America, Europe, and emerging markets, driven by high regulatory standards.

1. Major Pharmaceutical Manufacturers

Hospira, a Pfizer Company: Recognized as a leading supplier of injectable drugs and infusion solutions, Hospira offers piperacillin-tazobactam in vials and infusion bags. Their saline solutions in duplex containers are widely used across global hospitals. Hospira's manufacturing facilities adhere to stringent FDA and EMA standards, ensuring product quality and consistency [1].
Sandoz (Novartis Group): Sandoz manufactures generic formulations of piperacillin-tazobactam, including infusion solutions with sodium chloride in duplex containers. Their global distribution network ensures availability in multiple markets, including the U.S. and Europe [2].
Mitsubishi Tanabe Pharma Corporation: Provides high-quality injectable antibiotics, including piperacillin-tazobactam, in sterile multipurpose containers used for infusion preparation. Their focus on quality control aligns with global regulatory requirements [3].
GlaxoSmithKline (GSK): Offers piperacillin-tazobactam products for hospital use, with supply chains ensuring access to intravenous formulations, including sodium chloride diluents in duplex packaging.

2. Leading Generic and Regional Suppliers

APP Pharmaceuticals (an industry leader in sterile injectables in the U.S.): Supplies piperacillin-tazobactam in ready-to-administer formulations, including sodium chloride solutions in duplex containers, optimized for hospital use [4].
Fresenius Kabi: A dominant global provider of infusion therapies, including sodium chloride solutions packaged in duplex containers. Their formulations are compatible with various antibiotics, including piperacillin-tazobactam [5].
Baxter International: Offers a comprehensive portfolio of sterile injectable antibiotics and saline solutions, with duplex container packaging designed for easy reconstitution and administration [6].

3. Specialty and Regional Manufacturers

Emerging markets feature domestic manufacturers such as Zydus Cadila, Biocon, and Gland Pharma, which produce generic piperacillin-tazobactam and infusion solutions, often catering primarily to regional healthcare systems. Their adherence to international quality standards is increasing, facilitated by validation through WHO prequalification programs [7].

Supply Chain Considerations

Regulatory Approvals: Most suppliers comply with major regulatory standards such as the FDA (U.S.), EMA (Europe), and PMDA (Japan). For regional suppliers, WHO prequalification can be a marker of product quality for international procurement.
Packaging and Stability: Duplex containers facilitate in-situ reconstitution, reducing contamination risks and simplifying storage. Suppliers emphasizing stability data and validated sterilization processes ensure product integrity.
Manufacturing Capacity and Scalability: Leading firms continually expand manufacturing capacity to meet global hospital demands, especially during health crises (e.g., COVID-19 pandemic), emphasizing supply chain robustness.
Economic Factors: Generic manufacturers often offer cost-effective options, whereas branded suppliers provide assurance of product consistency and support services. Procurement agencies balance quality, reliability, and cost in sourcing decisions.

Key Manufacturers and Suppliers in Detail

Supplier	Key Products	Regulatory Certifications	Packaging Types	Geographical Focus
Pfizer (Hospira)	Piperacillin-tazobactam in duplex containers	FDA, EMA	Duplex vials, infusion bags	Global, U.S., Europe
Sandoz	Piperacillin-tazobactam	WHO PQ, FDA, EMA	Duplex infusion bags	Global regions
Fresenius Kabi	Sodium chloride solutions	ISO, FDA	Duplex sterile containers	Global, with regional supply chains
Baxter	Piperacillin-tazobactam & saline solutions	FDA, EMA	Duplex IV bags	Americas, Europe
Gland Pharma	Generic piperacillin-tazobactam	Indian GMP, WHO PQ	Duplex containers	India, Asia, emerging markets

Quality Assurance and Regulatory Compliance

Suppliers maintaining rigorous quality standards are preferred, especially in critical care settings. Certification by regulatory authorities and adherence to Good Manufacturing Practices (GMP) are non-negotiable determinants:

FDA Compliance: Ensures safety, efficacy, and manufacturing standards.
EMA Certification: Demonstrates adherence to European standards.
WHO Prequalification: Facilitates procurement for international health organizations and PMS programs in low- and middle-income countries.

Impact of Supply Chain Disruptions

Recent disruptions, driven by geopolitical tensions, pandemic-related manufacturing slowdowns, and logistical constraints, highlight the importance of diversified sourcing. Companies maintaining multiple manufacturing sites and engaging in strategic inventory management reduce risks associated with supply shortages.

Conclusion

The supply landscape for piperacillin and tazobactam combined with sodium chloride in duplex containers is characterized by a mix of multinational pharmaceutical giants and regional generic manufacturers. Prominent suppliers, such as Pfizer's Hospira, Sandoz, Fresenius Kabi, and Baxter, dominate global markets due to their robust regulatory compliance, extensive manufacturing capacity, and quality assurance programs. Regional players like Gland Pharma and Zydus Cadila serve emerging markets, often at lower costs, with increasing adherence to international standards.

The choice of suppliers depends on regional regulatory approvals, quality certifications, supply stability, and cost considerations. Ensuring supply security involves engaging with reputable, certified manufacturers and fostering relationships that support consistent procurement.

Key Takeaways

Major global suppliers like Pfizer (Hospira), Sandoz, Fresenius Kabi, and Baxter lead in manufacturing piperacillin-tazobactam and sodium chloride solutions in duplex containers, ensuring high-quality standards globally.
Regulatory compliance (FDA, EMA, WHO PQ) remains essential when selecting suppliers, especially for international procurement.
Regional and generic manufacturers provide cost-effective options, with increasing manufacturing quality aligning with international standards.
Supply chain resilience depends on diversification, vigilant quality control, and monitoring geopolitical developments impacting manufacturing and logistics.
Duplex packaging enhances safety, convenience, and stability, making it the preferred method for hospital infusion preparations.

FAQs

1. Are all suppliers of piperacillin-tazobactam in duplex containers certified by international regulators?
Not all suppliers, especially emerging market manufacturers, hold certifications like WHO prequalification or EMA approval. Procurement agencies should verify certifications to ensure product quality.

2. Can I source sodium chloride solutions separately if the duplex containers are unavailable?
Yes, sodium chloride 0.9% solutions are widely available separately, often in similar sterile container formats. However, duplex containers offer convenience and reduce contamination risks.

3. What are the benefits of using duplex containers for antibiotic infusion?
Duplex containers facilitate in-situ reconstitution, minimize contamination, reduce waste, and streamline hospital pharmacy workflows.

4. Which supplier offers the most cost-effective option for low-resource settings?
Regional generic manufacturers such as Gland Pharma and Zydus Cadila typically offer lower-cost alternatives, provided they meet local regulatory standards.

5. How can supply chain disruptions be mitigated for critical antibiotics like piperacillin-tazobactam?
Diversifying suppliers, maintaining strategic inventories, engaging with established manufacturers, and monitoring geopolitical risks are key strategies to ensure consistent supply.

References

[1] Pfizer. Hospira Piperacillin Tazobactam Product Details. Available at: [Hospital Pharmacy Portal].

[2] Sandoz. Antibiotics Portfolio. Sandoz Official Website.

[3] Mitsubishi Tanabe Pharma. Product Documentation. Available through regional distributors.

[4] APP Pharmaceuticals. Sterile Injectable Antibiotics Catalog. [Corporate Website].

[5] Fresenius Kabi. Infusion Solutions Product Line. Available at: [Fresenius Kabi Official].

[6] Baxter International. IV Solutions and Antibiotics. Corporate Website.

[7] WHO. Prequalification of medicines Programme. Guidelines and listing.

Suppliers and packagers for PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER